Depralin Odt

Leaflet accompanying the packaging: patient information

Depralin ODT, 5 mg, orally disintegrating tablets

Depralin ODT, 10 mg, orally disintegrating tablets

Depralin ODT, 20 mg, orally disintegrating tablets

Escitalopram

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Depralin ODT and what is it used for
• 2. Important information before taking Depralin ODT
• 3. How to take Depralin ODT
• 4. Possible side effects
• 5. How to store Depralin ODT
• 6. Contents of the packaging and other information

1. What is Depralin ODT and what is it used for

Depralin ODT belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing the level of serotonin. Disruption of the serotonin system in the brain is thought to be an important factor in the development of depression and related disorders.

Depralin ODT contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic attacks with or without agoraphobia, social anxiety disorder (social phobia), generalized anxiety disorder, obsessive-compulsive disorder).

It may take several weeks of treatment before you start to feel better. You should continue to take Depralin ODT even if it takes some time to feel better. If you do not feel better or feel worse, you should consult a doctor.

2. Important information before taking Depralin ODT

When not to take Depralin ODT

Warnings and precautions

You should discuss this with your doctor or pharmacist before starting to take Depralin ODT.

You should tell your doctor if you have any other disorders or diseases, as they may need to be taken into account. In particular, you should inform your doctor if:

• you have epilepsy. You should stop taking Depralin ODT if you have seizures or if the frequency of seizures increases (see also section 4 "Possible side effects");
• you have liver or kidney problems. Your doctor may need to adjust the dose;
• you have diabetes. Treatment with Depralin ODT may disrupt blood sugar control. You may need to adjust the dose of insulin and/or oral antidiabetic medicines;
• you have low sodium levels in the blood;
• you have an increased tendency to bleed or bruise, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• you are being treated with electroconvulsive therapy;
• you have coronary heart disease;
• you have had heart problems or have recently had a heart attack;
• you have low resting heart rate and/or may have electrolyte disturbances due to prolonged, persistent diarrhea and vomiting or the use of diuretics;
• you experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing, which may indicate abnormal heart function;
• you have had eye problems, such as certain types of glaucoma (increased pressure inside the eyeball);
• you have chronic pain that requires treatment with buprenorphine. Taking this medicine with Depralin ODT may lead to a life-threatening condition called serotonin syndrome (see section "Depralin ODT and other medicines").

Caution

In some patients with bipolar disorder (manic-depressive disorder), a manic phase may occur.

This is characterized by unusual, rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If you experience any of these symptoms, you should contact your doctor.

In the first few weeks of treatment, you may experience symptoms such as restlessness or inability to sit or stand still. If such symptoms occur, you should contact your doctor immediately.

Medicines like Depralin ODT (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety symptoms

If you have depression and/or anxiety disorders, you may sometimes have thoughts of self-harm or suicide. These thoughts may increase when you first start taking antidepressant medicines, as these medicines usually start to work after about 2 weeks, and sometimes it takes longer.

The risk of such thoughts is higher if:

• you have had suicidal thoughts or self-harm in the past;
• you are an adult in your young age. Information from clinical trials indicates an increased risk of suicidal behavior in adults under 25 years of age with mental disorders who were treated with antidepressant medicines.

If you experience suicidal thoughts or thoughts of self-harm at any time, you should contact your doctor or go to the hospital immediately. You should also tell someone from your family or close friends about your depression or anxiety disorder and ask them to read this leaflet. You may ask them to tell you if they notice that your depression or anxiety symptoms have worsened or if you have any worrying changes in your behavior.

Children and adolescents

Depralin ODT should not normally be used for children and adolescents under 18 years of age.

It should be remembered that in patients under 18 years of age taking medicines of this group, there is a greater risk of side effects, such as suicidal attempts and suicidal thoughts, as well as hostility (especially aggression, rebellious behavior, and manifestations of anger). However, your doctor may prescribe Depralin ODT to patients in this age group if they consider it necessary. If your doctor has prescribed Depralin ODT to a patient under 18 years of age and you have any doubts, you should consult your doctor again. You should contact your doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Depralin ODT. The long-term safety of Depralin ODT regarding its impact on growth, maturation, and cognitive and behavioral development has not been established in this age group.

Depralin ODT and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

You should inform your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (IMAOs) containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine. If you are taking any of these, you should wait 14 days before starting to take Depralin ODT. After stopping Depralin ODT, you should wait 7 days before starting to take any of these medicines.
• Reversible selective MAO-A inhibitors, such as moclobemide (used to treat depression).
• Irreversible MAO-B inhibitors, such as selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used to treat manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (used to treat depression).
• Sumatriptan and similar medicines (used to treat migraines) and tramadol, buprenorphine (opioid medicines used to treat acute or chronic pain). You should not take escitalopram with these medicines without consulting your doctor first. These medicines may interact with Depralin ODT and cause symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and body temperature above 38°C. If you experience such symptoms, you should contact your doctor.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the level of Depralin ODT in the blood.
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory medicines (used to treat pain or to thin the blood, so-called blood thinners). These medicines may increase the risk of bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will probably check your blood clotting time before and after stopping treatment with Depralin ODT to see if the dose of anticoagulant medicine is still appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the risk of lowering the seizure threshold.
• Antipsychotics (used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold.
• Flecainide, propafenone, metoprolol (used to treat cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of Depralin ODT.
• Medicines that may decrease potassium or magnesium levels in the blood, due to the increased risk of life-threatening heart rhythm disorders.

You should not take Depralin ODT if you are taking medicines used to treat heart rhythm disorders or medicines that affect heart rhythm, such as:

class IA and III antiarrhythmic medicines, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines - especially halofantrine), and certain antihistamines (astemizole, mizolastine). If you have any further doubts, you should consult your doctor.

Depralin ODT with food, drink, and alcohol

Depralin ODT should not be taken with food (see section 3 "How to take Depralin ODT").

As with many other medicines, it is not recommended to drink alcohol during treatment with Depralin ODT, although no interaction with alcohol is expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.

You should not take Depralin ODT if you are pregnant or breastfeeding, unless your doctor has discussed the risks and benefits of taking the medicine with you.

Pregnancy

Taking Depralin ODT at the end of pregnancy may increase the risk of severe bleeding from the vagina, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Depralin ODT, you should tell your doctor or midwife so that they can give you appropriate advice.

If you are taking Depralin ODT in the last three months of pregnancy, you should be aware that the following symptoms may occur in the newborn: difficulty breathing, bluish discoloration of the skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness of the muscles, increased reflexes, tremors, tremors, lethargy, irritability, constant crying, or difficulty sleeping. If any of these symptoms occur in the newborn, you should contact your doctor immediately.

You should make sure that your midwife and/or doctor know that you are taking Depralin ODT.

Taking Depralin ODT during pregnancy, especially in the last three months, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN). This causes rapid breathing and bluish discoloration of the newborn's skin. These symptoms usually appear in the first day after birth. If you notice these symptoms in your newborn, you should contact your midwife and/or doctor immediately.

You should not stop taking Depralin ODT during pregnancy unless your doctor tells you to.

Breastfeeding

It is assumed that Depralin ODT passes into breast milk.

Fertility

In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

You should not drive or operate machinery until you are sure how Depralin ODT affects you.

Depralin ODT contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking Depralin ODT.

Depralin ODT contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is essentially "sodium-free".

3. How to take Depralin ODT

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

Depralin ODT, orally disintegrating tablets, should be taken once daily, in one dose. The medicine should not be taken with food.

The orally disintegrating tablets are fragile, so you should handle them carefully. You should not touch the tablets with wet hands, as they may break apart.

• 1. Holding the blister by the edges, separate one tablet from the rest of the strip by gently tearing it off along the perforation.
• 2. Carefully peel off the rear foil.
• 3. Place the tablet on your tongue. The tablet will dissolve very quickly and can be swallowed without water.

Adults

Depression

The usual dose is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.

Anxiety disorder with panic attacks (panic disorder)

The recommended initial dose of Depralin ODT is 5 mg once daily for the first week, which is then increased to 10 mg once daily. Your doctor may recommend further increasing the dose to a maximum of 20 mg once daily.

Social anxiety disorder

The usual dose of Depralin ODT is 10 mg once daily. Depending on your response to the medicine, your doctor may decrease the dose to 5 mg once daily or increase the dose to a maximum of 20 mg once daily.

Generalized anxiety disorder

The usual dose of Depralin ODT is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.

Obsessive-compulsive disorder

The usual dose of Depralin ODT is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.

Elderly patients (over 65 years of age)

The recommended initial dose of Depralin ODT is 5 mg once daily. Your doctor may increase the dose to 10 mg once daily.

Children and adolescents

Depralin ODT is not normally used for children and adolescents. For more information, see section 2 "Important information before taking Depralin ODT".

Duration of treatment

It may take several weeks of treatment before you feel better. You should continue to take the medicine, even if you do not feel better at first.

You should never change the dose of the medicine without consulting your doctor first.

You should continue to take Depralin ODT for as long as your doctor has prescribed. If you stop treatment too early, your symptoms may return. It is recommended that treatment be continued for at least 6 months after you start to feel better.

Taking a higher dose of Depralin ODT than recommended

If you have taken more Depralin ODT than prescribed, you should contact your doctor or go to the emergency room immediately. You should do this even if you do not feel any discomfort. Some of the symptoms of overdose are dizziness, tremors, agitation, seizures, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and disturbances in the body's water and electrolyte balance. You should take the packaging (box) of Depralin ODT with you to the doctor's office or hospital.

Missing a dose of Depralin ODT

You should not take a double dose of the medicine to make up for a missed dose. If you forget to take a dose and remember before going to bed, you should take the missed dose immediately. You should take the next dose at the usual time the next day. If you remember that you have missed a dose in the night or the next day, you should skip the missed dose and take the next dose at the usual time.

Stopping treatment with Depralin ODT

You should not stop taking Depralin ODT unless your doctor tells you to.

If you are finishing the prescribed treatment cycle, it is usually recommended to gradually decrease the dose of Depralin ODT over several weeks.

If you stop taking Depralin ODT, especially if you stop suddenly, you may experience withdrawal symptoms. These symptoms are often seen when escitalopram treatment is stopped. The risk is higher if the medicine was taken for a long time or in high doses, or if the dose was decreased too quickly. In most patients, the symptoms are mild and go away on their own within two weeks. However, in some patients, they may be severe and last longer (2 to 3 months or longer). If you experience severe withdrawal symptoms, you should contact your doctor. Your doctor may recommend that you start taking the medicine again and then stop it more slowly.

Withdrawal symptoms include dizziness (unsteady gait, balance disturbances), tingling, numbness, and (less commonly) electric shock-like sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headaches, nausea, excessive sweating (including night sweats), restlessness or agitation, tremors, confusion or disorientation, mood swings or irritability, diarrhea (loose stools), vision disturbances, and heart palpitations.

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Depralin ODT can cause side effects, although not everybody gets them.

Side effects usually go away after a few weeks of treatment. You should be aware that many symptoms can also be symptoms of the underlying disease and will go away as you feel better.

If you experience any of the following side effects during treatment, you should contact your doctor or go to the hospital immediately:

Uncommon (may affect up to 1 in 100 people):

• Abnormal bleeding, including bleeding from the gastrointestinal tract.

Rare (may affect up to 1 in 1,000 people):

Allergic reactions (such as swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing)

High fever, agitation, confusion (disorientation), tremors, and sudden muscle contractions, which can be symptoms of a rare disorder called serotonin syndrome.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Difficulty urinating
• Seizures (see also "Warnings and precautions")
• Yellowing of the skin and whites of the eyes, which are symptoms of liver dysfunction and/or hepatitis
• Rapid or irregular heartbeat, fainting, which can be symptoms of a life-threatening condition called Torsade de Pointes
• Suicidal thoughts and behaviors, see also "Warnings and precautions"
• Severe bleeding from the vagina, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.

In addition to the above, the following side effects have been reported with medicines with a similar mechanism of action to escitalopram (the active substance of Depralin ODT):

• Restlessness (akathisia)
• Loss of appetite

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Depralin ODT

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton.

The expiry date refers to the last day of the month stated.

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.

There are no special storage instructions; store in the original packaging to protect from moisture and light.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Depralin ODT contains

• The active substance of Depralin ODT is escitalopram. Depralin ODT 5 mg: Each tablet contains 5 mg of escitalopram, which corresponds to 6.3875 mg of escitalopram oxalate. Depralin ODT 10 mg: Each tablet contains 10 mg of escitalopram, which corresponds to 12.775 mg of escitalopram oxalate. Depralin ODT 20 mg: Each tablet contains 20 mg of escitalopram, which corresponds to 25.55 mg of escitalopram oxalate.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium carboxymethylcellulose, potassium polacrilin, potassium acesulfame, neohesperidin dihydrochalcone, magnesium stearate;

peppermint flavor containing corn maltodextrin, modified starch, and peppermint oil; concentrated hydrochloric acid.

What Depralin ODT looks like and contents of the pack

Depralin ODT 5 mg: round, white or almost white, flat tablet with beveled edges, 7 mm in diameter, with the inscription "5" on one side.

Depralin ODT 10 mg: round, white or almost white, flat tablet with beveled edges, 9 mm in diameter, with the inscription "10" on one side.

Depralin ODT 20 mg: round, white or almost white, flat tablet with beveled edges, 12 mm in diameter, with the inscription "20" on one side.

Depralin ODT is available in packs of 7, 28, 30, and 90 orally disintegrating tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Genepharm S.A.

18th km Marathonos Ave,

Pallini Attiki, 15351

Greece

PharmaPath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands - Escitalopram Polpharma 5 mg orodispergeerbare tabletten

Escitalopram Polpharma 10 mg orodispergeerbare tabletten

Escitalopram Polpharma 15 mg orodispergeerbare tabletten

Escitalopram Polpharma 20 mg orodispergeerbare tabletten

Date of last revision of the leaflet:November 2023